A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00250562
First received: November 6, 2005
Last updated: November 7, 2011
Last verified: June 2006
  Purpose

Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries worldwide for the treatment of hypertension. In China the usual recommended starting and maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. This fixed combination is registered in most countries worldwide.

The potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients.

This study is not recruiting in the US.


Condition Intervention Phase
Hypertension
Drug: valsartan plus hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Active Controlled, Parallel Group Trial Comparing the Combinations of Valsartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Valsartan 80 mg in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80mg

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline diastolic blood pressure after 8 weeks

Secondary Outcome Measures:
  • Change from baseline systolic blood pressure after 8 weeks
  • Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks

Enrollment: 1171
Study Start Date: October 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • - Male or female Outpatients 18 years and older.
  • Patients with hypertension defined as the following:
  • Newly diagnosed hypertensive patients should have a MSDBP > 95 mmHg and < 110 mmHg.at Visit 1 and 2, Pre-treated hypertensive patients should have a MSDBP > 95 mmHg and < 110 mmHg at Visit 2
  • For entrance into the double-blind treatment period (Visit 3), all patients should have a MSDBP of > 90 mmHg and < 110 mmHg
  • Patients must have given written informed consent to participate and be willing to participate in the entire study

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250562

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceutical Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00250562     History of Changes
Other Study ID Numbers: CVAH631A2302
Study First Received: November 6, 2005
Last Updated: November 7, 2011
Health Authority: China: Ministry of Health

Keywords provided by Novartis:
Hypertension
Angiotensin II receptor blocker
fixed combination
diuretics

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014